Everest Medicines Licensing Partner Pfizer Reports the US FDA and EMA’s Acceptance of NDA and MAA for Etrasimod in Ulcerative Colitis
Shots:
- The US FDA has accepted an NDA for review of etrasimod & EMA also accepted the MAA for active UC. The US FDA & EMA decision are expected in H2’23 & H1’24
- The submissions were based on the P-III (ELEVATE UC 52 & 12) trials evaluating etrasimod (2mg, qd) vs PBO. Both trials met their 1EPs & 2EPs i.e., clinical remission (27.0% & 24.8% vs 7.4% & 15.2%) @12wks.; 32.1% vs 6.7% @52wk. in (ELEVATE UC 52) along with corticosteroid-free remission & sustained clinical remission @52wk.
- Improvements in 2EPs incl. endoscopic improvement, symptomatic remission & mucosal healing @12 & 52wk. in (ELEVATE UC 52) & @12wk. in (ELEVATE UC 12) & the safety profile was consistent with prior studies. In (ELEVATE UC 12), similar patients experienced TEAEs while in (ELEVATE UC 52) it was higher in etrasimod
Ref: Business Wire | Image: Pfizer
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